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Completed

NCT Number: NCT04859881

Risk Factors for Barotrauma in COVID-19

Barotrauma in mechanical ventilation (MV) is defined as lung damage attributable to the application of high airway pressure and is one of the potential mechanisms of ventilator-induced lung injury (VILI). Previous studies have shown an increased mortality in patients with barotrauma under MV; pneumothorax (PTX) being the most common presentation, but it can also present as pneumomediastinum (PM) with or without PTX, with extension to soft tissue as subcutaneous emphysema or even as pneumo-retroperitoneum and pneumo-scrotum.

Traditionally, underlying lung disease or age are known risk factors for non-trauma related barotrauma. However, in patients with novel coronavirus disease (COVID-19), the incidence of this complication is more common than in non-infected patients, as recently reported. Since little is known regarding which are the main risk factors for these events to develop, most pathophysiological mechanisms remain unexplained.

The aim of this study was to determine the risk factors for developing barotrauma in patients under MV with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). Secondary objectives were to determine the incidence of barotrauma and its association with mortality.

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Key information

Conditions

Barotrauma COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Ajusco Medio

Mexico City, 14250, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients under MV fulfilling the Berlin definition for ARDS, with positive SARS-COV2 real time polymerase chain reaction

Exclusion criteria

  • Incomplete clinical records and other causes of extrapulmonary air

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Barotrauma development

    Time frame: During patient hospitalization, an average of one month

    Diagnosis of barotrauma in patients under mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome

Secondary outcomes

  1. Mortality

    Time frame: During patient hospitalization, an average of one month

    Dead of patient

Sponsors and collaborators

Lead sponsor

Hospital General Ajusco Medio

Other

Collaborators

  • Carlos Torruco-Sotelo
  • Horacio Marquez-Gonzalez
  • Sebastian Rodriguez-Llamazares

Registry information

Official study title

Risk Factors Associated With Barotrauma in COVID-19 Patients

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2021
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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